The Center for Regulatory Effectiveness (CRE) has notified the FDA that the smoking initiation/cessation studies identified by the FDA and reviewed by CRE can not be used to formulate a policy on menthol cigarettes.

The Data Quality Act prohibits federal agencies from using studies that are non-compliant with the DQA. The FDA has sixty days to respond to the CRE petition.

In its petition CRE painstakingly reviews eight of the studies identified by the FDA and explains the reasons for their non-compliance with the Data Quality Act.

In its petition CRE states:

“As explained at the outset of this petition, OMB has required that agency materials submitted to a committee for peer review purposes display a disclaimer that the materials are being disseminated for peer review purposes only and do not represent an agency position. Adding such a disclaimer at this late date, however, would not be an adequate remedy. The materials (FDA slides, verbal presentations, and recording of the webcast) have already been presented to the TPSAC, and have been disseminated to the public for a substantial period of time, without such a disclaimer, so that the harm associated with dissemination without the disclaimer must be redressed by the additional corrective actions requested herein.”

It is for this reason that the requested relief includes a statement by the FDA that the eight studies are not in compliance with the Data [Information] Quality Act and therefore can not be used by the agency in its formulation of a policy on menthol cigarettes.

See the attachment below for a copy of the CRE DQA Petition and supporting materials.